NCT05584527

Brief Summary

Military personnel and athletes have a very high energy expenditure which is increased during certain key periods (intense training, competition and mission). Compensating for this expenditure through food can be complicated by physiological ingestive limits and logistical and organizational constraints (number of meals, availability of food), which leads these populations to regularly experience energy deficit situations (intake below requirements), which could alter physical and cognitive performance and major physiological functions. Among the many constraints to which military personnel and athletes are exposed to (stress, sleep deprivation, travel, etc.) that can increase the risk of energy deficits, the impact of thermal environmental constraints is not well known. The seasonal impact and travel to countries with very different thermal environments can lead these populations to experience cold and hot conditions for long periods. Understanding how heat and cold exposure modifies appetite and energy intake therefore appears to be of great importance. The hypothesis of this study is that a 24 h heat exposure would produce a rapid and long-lasting anorexigenic action impacting energy intake, while a cold exposure would produce the opposite effect (orexigenic action).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 28, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

2.4 years

First QC Date

October 14, 2022

Last Update Submit

December 8, 2022

Conditions

Keywords

Heat ExposureFood Intake

Outcome Measures

Primary Outcomes (1)

  • Total energy intake (in kilojoules) measured at the end of each condition (heat exposure, cold exposure and thermoneutral exposure)

    Through study completion (30 months)

Interventions

The participants will be exposed to heat (32°C) for 24 hours in a climatic apartment. During the exposure, * food intake and energy expenditure will be measured * several physiological tests will be performed: hunger and thirst questionnaires, thermal sensations, skin temperature measurement, weighing, olfactory and gustatory capacities, food preference questionnaire, etc. * sleep brain activity will be monitored using a headband * urine and saliva samples will be collected.

The participants will be exposed to cold (16°C) for 24 hours in a climatic apartment. During the exposure, * food intake and energy expenditure will be measured * several physiological tests will be performed: hunger and thirst questionnaires, thermal sensations, skin temperature measurement, weighing, olfactory and gustatory capacities, food preference questionnaire, etc. * sleep brain activity will be monitored using a headband * urine and saliva samples will be collected.

The participants will be exposed to a thermoneutral environment (24°C) for 24 hours in a climatic apartment. During the exposure, * food intake and energy expenditure will be measured * several physiological tests will be performed: hunger and thirst questionnaires, thermal sensations, skin temperature measurement, weighing, olfactory and gustatory capacities, food preference questionnaire, etc. * sleep brain activity will be monitored using a headband * urine and saliva samples will be collected.

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will be composed of young and healthy men.

You may qualify if:

  • Male
  • Aged 18 to 40 years old
  • Active (≥ 3 hours of physical activity per week)
  • Healthy (no metabolic pathology)
  • Affiliated to the social security system
  • Having given written consent to participate.

You may not qualify if:

  • Unusual eating pattern (\< 3 meals per day) or irregular eating pattern
  • Pattern of dietary restriction (determined by the Three-Factor Eating Questionnaire-21)
  • Unusual sleep pattern (Epworth score \> 10, insomnia severity score \> 14, Pittsburgh Sleep Quality Index \> 5), sleep duration \< 6 h per night or difficulty falling asleep)
  • Metabolic pathology
  • On medication
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva and blood samples will be collected during each experimental visit : * saliva samples will be collected to measure salivary cortisol level. * blood samples will be collected to measure plasma levels of acylated ghrelin, leptin, peptide YY and Glucagon-like peptide-1.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2022

First Posted

October 18, 2022

Study Start

November 28, 2022

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

December 9, 2022

Record last verified: 2022-12

Locations